A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

This study has been suspended.

First Received: January 20, 2004 Last Updated: January 31, 2006 History of Changes

Sponsored by:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00076323

Purpose

This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.

Condition	Intervention
Glucosephosphate Dehydrogenase Deficiency Favism	Drug: Primaquine

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: glucose-6-phosphate dehydrogenase deficiency

Drug Information available for: Primaquine phosphate Primaquine

U.S. FDA Resources

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.

Estimated Enrollment:	14
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

Normal clinical evaluation
Willing and able to make all scheduled visits

Exclusion:

pregnant or planning pregnancy
Have taken any anti-malarial medication in past month
Positive blood tests for HIV and specific types of hepatitis
Allergic to primaquine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076323

Locations

United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Shon A Remich

WRAIR, Experimental Therapeutics

More Information

Additional Information:

Recruitment page for WRAIR Clinical Trials Center This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	WRAIR 992, G6PD
Study First Received:	January 20, 2004
Last Updated:	January 31, 2006
ClinicalTrials.gov Identifier:	NCT00076323 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

G6PD
Favism
G6PD Deficiency

hemolysis
drug reaction
drug-induced hemolysis

Study placed in the following topic categories:

Primaquine
Metabolic Diseases
Hematologic Diseases
Glycogen Storage Disease
Anemia
Poisoning
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic
Disorders of Environmental Origin
Glycogen Storage Disease Type I

Antimalarials
Von Gierke Disease
Anemia, Hemolytic, Congenital
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hemolysis
Glucose 6 Phosphate Dehydrogenase Deficiency
Favism
Metabolic Disorder

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Primaquine
Metabolic Diseases
Hematologic Diseases
Glycogen Storage Disease
Food Poisoning
Anemia
Poisoning
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic
Disorders of Environmental Origin

Glycogen Storage Disease Type I
Plant Poisoning
Pharmacologic Actions
Antimalarials
Metabolism, Inborn Errors
Anemia, Hemolytic, Congenital
Antiparasitic Agents
Genetic Diseases, Inborn
Therapeutic Uses
Favism
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on July 02, 2009